Kornimate/medical-research-clean huggingface dataset:
medication adherence in copd--a self-regulation study

Conditions: Lung Diseases, Obstructive; Bronchitis; Emphysema; Chronic Obstructive Pulmonary Disease

Summary: to test the effectiveness of a self-management program for chronic obstructive disease (copd) patients. the program to improve adherence could be conducted by nurses or other clinic staff in settings where comprehensive rehabilitation services were not available.

background: in 1990, the available data on medication adherence among chronic obstructive pulmonary disease (copd) patients consistently indicated that adherence was a significant problem. this was a particularly distressing finding, considering that pharmacological therapy was considered the backbone of copd management in settings where comprehensive rehabilitation services were limited. despite the importance of this issue and a large data base on how to enhance medication adherence among medical populations, there had been no empirical investigations evaluating the implementation of these strategies with copd patients. design narrative: the prospective, controlled study randomized 230 emphysema and chronic bronchitis patients from an urban university medical center into either a "usual care", control group or into a self-management skills training program for improving adherence. the training program was based on self-management procedures for enhancing adherence which had proven efficacious with diverse populations. self-reported and objective measures of adherence were examined during the two month baseline period and the one year follow-up in the controlled study. a range of possible covariates including demographics, patient characteristics, treatment, and therapeutic outcome variables were also collected during the baseline phase and at the 6-month and 12-month follow-up visits in the controlled study to evaluate their relationship to the observed adherence levels. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
tolerance of targeted therapy used in metastatic melanoma in patients aged over 65 and 75-year-old

Conditions: Metastatic Melanoma

Summary: since 2013, therapeutic care of metastatic melanoma (mm) has greatly improved, especially thanks to braf and mek targeted therapies. the efficacy of these treatments that are now used daily at first line for braf mutated mm is widely approved. their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas... however, onco-dermatologists are more and more faced with mm of elderly patients. indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. these patients are still active but much more vulnerable. nevertheless, there is no data in the literature for this fragile population except the mm pivotal studies subgroups of those over 65-year-old. the results vary with different regimens. therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of braf and mek inhibitors in elderly patients

since 2013, therapeutic care of metastatic melanoma (mm) has greatly improved, especially thanks to braf and mek targeted therapies. the efficacy of these treatments that are now used daily at first line for braf mutated mm is widely approved. their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas... however, onco-dermatologists are more and more faced with mm of elderly patients. indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. these patients are still active but much more vulnerable. nevertheless, there is no data in the literature for this fragile population except the mm pivotal studies subgroups of those over 65-year-old. the results vary with different regimens. therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of braf and mek inhibitors in elderly patients. this work aims to study the targeted therapies tolerance in over 65 or 75-year-old patients with braf mutated mm. the french clinical and biological database melbase will be analysed to carry out a descriptive retrospective multicentric study. this real-life assessment of the adverse effects in older patients will result in more adapted therapeutic decisions, better informed patients and improved follow-up care in order to increase quality of life and life expectancy.

Eligibility criteria:
inclusion criteria: * metastatic melanoma exclusion criteria: * none

Keywords: melanoma elderly tolerance adverse effects targeted therapies
roy adaptation model based strengthening program and social media addiction

Conditions: Social Media Addiction

Summary: in this pretest-posttest, randomized controlled study, the effect of the empowerment program developed based on roy adaptation on the healthy lifestyle behaviors, self-esteem and social media addiction of nursing students will be examined. the hypothesis of this study is that the empowerment program based on roy adaptation model reduces social media addiction, increases healthy lifestyle behaviors and self-esteem.

the universe of this study was composed of 411 nursing students studying at mersin university's faculty of nursing.the data were collected using the bergen social media addiction scale from 384 nursing students who accepted to participate in the study between 09 january 2020 - 09 march 2020.from the scale developed by andresan et al in 2017 and adapted to turkish by demirci in 2019, 110 nursing students who scored 3 or more out of at least 4 out of 6 items or scored 18 or more out of the total score constituted the sample of the study.110 nursing students were assigned to the experimental and control groups (55 experimental and 55 control groups) by block randomization.7 separate focus group sessions were held online between 01 september 2020 - 01 october 2020 with 55 student nurses in the experimental group. using the literature and data obtained from the first stage of the study (analysis of focus group sessions), a strengthening program based on the roy adaptation model was made.the necessary corrections and additions were made to the program by obtaining expert opinions from field experts regarding the program created. empowerment program based on roy adaptation model will be applied to 55 student nurses in the experimental group between 01 february 2021 - 01 may 2021 through online group sessions. the bergen social media addiction scale, rosenberg self-esteem scale and healthy lifestyle behaviors scale, which were applied as a pre-test in the first session of the application, will be applied as a post-test in the 12th session.

Eligibility criteria:
inclusion criteria: * agreeing to participate in research * students who score 3 or more out of at least 4 out of 6 items or score 18 or more out of the total score in the bergen social media addiction scale. exclusion criteria: * who do not agree to participate in the research * students who scored 3 or less from at least 3 out of 6 items in the bergen social media addiction scale, or who scored 17 or less out of the total score

Keywords: social media addiction empowerment nursing roy adaptation model
efficacy and safety study of secukinumab in chinese participants with non-radiographic axial spondyloarthritis

Conditions: Non-radiographic Axial Spondyloarthritis

Summary: the purpose of this study is to evaluate efficacy, safety and tolerability of secukinumab in chinese patients with active nr-axspa. treatment difference of secukinumab 150mg vs. placebo in chinese nr-axspa patients in terms of asas 40 response rate as well as safety profile will be provided by the study.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-nursing female patients at least 18 years of age * diagnosis of axial spondyloarthritis according to ankylosing spondyloarthritis international society (asas) axial spondyloarthritis criteria * objective signs of inflammation (magnetic resonance imaging (mri) or abnormal c-reactive protein) * active axial spondyloarthritis as assessed by total bath ankylosing spondylitis disease activity index \>=4 cm * spinal pain as measured by bath ankylosing spondylitis disease activity index question #2 ≥ 4 cm (0-10 cm) at baseline * total back pain as measured by visual analogue scale ≥ 40 mm (0-100 mm) at baseline * patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response * patients who have been on a tnfα inhibitor (not more than one) must have experienced an inadequate response exclusion criteria: * patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally * inability or unwillingness to undergo mri * chest x-ray or mri with evidence of ongoing infectious or malignant process * patients taking high potency opioid analgesics * previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (il-17) or il-17 receptor * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: non-radiographic spondyloarthritis chronic inflammatory disease inflammatory back pain, secukinumab ain457
evaluation of dynamic stability in the low back pain patient

Conditions: Low Back Pain; Chronic Low Back Pain

Summary: the main objective of this study is to compare on day 0 the maximum lyapunov exponent (lmax, an indicator of local dynamic stability) of chronic low back pain patients versus that of healthy volunteers matched for age (± 5 years), sex and body mass index (bmi ± 15% of low back pain patients).

the secondary objectives of this study are: to compare lmax in the different experimental conditions within each group (chronic lower back pain patients, healthy volunteers). to compare changes in lmax for low back pain patients at d7 and 6 weeks.

Eligibility criteria:
general inclusion criteria: * the patient/subject must have given his/her informed and signed consent * the patient/subject must be insured or beneficiary of a health insurance plan inclusion criteria for low back pain patients: * the patient has chronic low back pain lasting for more than 6 months and which is not postoperative in nature general exclusion criteria: * the patient/subject is participating in another study * the patient/subject is in an exclusion period determined by a previous study * the patient/subject is under judicial protection, under tutorship or curatorship * the patient/subject refuses to sign the consent * it is impossible to correctly inform the patient/subject * the patient/subject is pregnant, parturient, or breastfeeding exclusion criteria for low back pain patients: * the patient has a history of spinal surgery * the patient has a history of preexisting postural disorder related to lumbalgia * the patient has undergone a localized infiltration treatment (e.g. cortisone shots) in the last month * the subject has a balance disorder, blindness, inability to carry out the experimental protocol exclusion criteria for healthy volunteers: * the subject has a history of acute low back pain \> 15 days or which has resulted in a work stoppage of more than 7 days in the 5 years preceding the study
efficacy and safety of empagliflozin in gsd-ib patients

Conditions: Glycogen Storage Disease Type IB

Summary: empagliflozin treatment of gsd-1b patients

glycogen storage disease type ib (gsd-ib) is a type of genetic disease with a prevalence of approximately 1 in 500,000. in addition to phenotypes common to gsd-i such as hypoglycemia, hypoglycemia, lactatemia, hyperlipidemia, hyperuricemia, and hepatomegaly, gsd-ib patients also experience neutropenia and dysfunction, causing infections and inflammatory bowel disease (ibd). at present, the only available treatment for neutropenia in gsd-ib patients is subcutaneous injection of granulocyte-colony stimulating factor (g-csf). g-csf increases the number of neutrophils, but does not improve neutrophil dysfunction, and is also associated with the risk of concurrent splenomegaly and malignancy. the most recent research findings demonstrated that substantial accumulation of 1,5-anhydroglucitol-phosphate is the cause of neutropenia and neutrophil dysfunction in gsd ib patients. empagliflozin, an sglt2 inhibitor, is an efficient and secure approach of treating neutropenia in these patients by inhibiting renal glucose and 1,5-anhydroglucitol reabsorption. our study's objective is to assess the efficacy and safety of empagliflozin (jardiance®) in patients with gsd ib.

Eligibility criteria:
inclusion criteria: 1. patients with glycogen storage disease type ib (genetically diagnosed) aged ≥ 1 year and ≤ 50 years; 2. patients meet the diagnostic criteria for crohn's disease (cd) based on expert consensus on the diagnosis and treatment of inflammatory bowel disease in chinese children (2019) or consensus opinion on the diagnosis and treatment of inflammatory bowel disease in china (2018), or patients meet the diagnostic criteria for recurrent respiratory tract infection based on clinical diagnosis and treatment for recurrent respiratory tract infection in chinese children (2022); 3. subjects and their guardians/clients (\< 18 years old) or subjects (≥ 18 years old) signed the informed consent form. exclusion criteria: 1. patients with chronic kidney disease (egfr \< 60 ml/min/1.73 m\^2) or cirrhosis (metavir f4); 2. experiencing symptomatic or severe hypoglycemia within 1 month before the start of this trial; 3. absolute neutrophil count continued ≥ 1.5 × 10\^9/l (≥ 3 tests, each interval ≥ 5 days); 4. current active urinary tract infection (until urine routine twice negative); 5. participating other clinical investigators in the past 1 month; 6. pregnancy, breast-feeding and having a pregnancy plan; 7. presence of contraindications to empagliflozin therapy (hypersensitivity to empagliflozin, current or history of gangrene, history of recurrent urinary or genital infections); 8. patients who are not suitable for participating in the clinical investigator or with low compliance in the investigator 's opinion.
validation of bodpod in pediatric anorexia nervosa

Conditions: Anorexia Nervosa

Summary: anorexia nervosa is a severe cause of undernutrition. it leads to a dramatic decrease of weight with an important modification of the body composition. during the renutrition phase, disharmonious body composition recovery is a relapse factor. dual x-ray absorptiometry (dxa) is the gold standard to study body composition in children with anorexia nervosa. but, due to technical limits, dxa analysis needs to take in account a potential failure to thrive with an adjustment on height. moreover dxa needs an irradiation which does not allow close repeat measurements. since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (adp). actually, only one device is available for this measurement: the bodpod®. however, feasibility and accuracy of adp compare to dxa have not been evaluated in pediatric anorexia nervosa. the aim of this study is to compare the accuracy of bodpod® compare to dxa in girls with anorexia nervosa.


Eligibility criteria:
inclusion criteria: * female patients aged between 8 and 18 years * female with a diagnosis of anorexia nervosa according to the dsm v classification, restrictive type or hyperphagic / purgative access type, evolving for less than 3 years. * female who received explanations adapted to their level of understanding for this study * female who expressed their consent to participate to this study * female whose parents or holders of parental authority have been informed and signed free and informed consent * female affiliated to a social security scheme exclusion criteria: * patients with psychotic symptoms * patients with claustrophobia * patients with severe respiratory disease
the role of balneotherapy in obese patients with knee osteoarthritis

Conditions: Knee Osteoarthritis, Obesity

Summary: the aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "servizio sanitario nazionale" (nhs).


Eligibility criteria:
inclusion criteria: * obesity ii-iii grade (bmi 35-45 kg/m2) * knee pain * patient compliance to the treatment exclusion criteria: * bmi\ 45,1kg/m2 * previous knee surgery * complicated diabetes mellitus * ischemic cardiomyopathy and heart failure * acute phase of osteoarthritis * varicose veins, deep venous thrombosis (dvt) * cancer * cutaneous lesions * nsaids administration \<1 week before the treatment * knee infiltration \<2 months before the treatment
longitudinal study of the clinical and haematological cause of women with antiphospholipid antibodies.

Conditions: Antiphospholipid Syndrome

Summary: this study is being done to see if there are any long term health related issues in women with apa and recurrent miscarriages.

the association between apa and thrombosis is well documented. both la and aca are often detected in individuals with sle but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with apa. this study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (paps) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.

Eligibility criteria:
inclusion criteria: antiphospholipid syndrome history of recurrent miscarriages exclusion criteria: previous thromboembolic disease

Keywords: antiphospholipid syndrome
health effects of particulate acids in late adolescence

Conditions: Airway Obstruction; Cough

Summary: this study was designed to follow a group of adolescents who were previously examined by questionnaire and pulmonary function tests when they were aged 8-10 years old. approximately 50% of the population in 10 towns were seen again at age 17-18. questionnaires and pulmonary function were repeated. the hypotheses being tested related to whether the previously seen levels of pulmonary function that were related to pollution levels in the towns persisted as the lungs of these children grew and whether dietary antioxidants influences level of attained pulmonary function.


Eligibility criteria:
children seen in a previous study at ages 8-10 from selected cities

Keywords: fev smoking antioxidents lung growth
a study of the effectiveness and safety of nivolumab compared to bevacizumab and of nivolumab with or without ipilimumab in glioblastoma patients

Conditions: Recurrent Glioblastoma

Summary: the purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as gbm), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of gbm therapy.

allocation: randomized (cohorts 1, 2 and part b of 1c/1d), non-randomized (cohorts 1b, and part a of 1c/1d)

Eligibility criteria:
inclusion criteria: * participants with histologically confirmed grade iv malignant glioma * previous treatment with radiotherapy and temozolomide (cohorts 1, 1b and 2 only) * first recurrence of gbm (cohorts 1, 1b and 2 only) * first diagnosis of gbm with resectable disease (cohorts 1c part a only) * first diagnosis of unmethylated mgmt gbm (cohort 1d and cohort 1c part b only) * karnofsky performance score of 70 or higher exclusion criteria: * more than 1 recurrence of gbm (cohorts 1, 1b and 2 only) * any recurrence of gbm (cohorts 1c and 1d only) * presence of extracranial metastatic or leptomeningeal disease * active, known or suspected autoimmune disease * clinically significant cardiovascular disease * prior bevacizumab or other vascular endothelial growth factor (vegf) or anti-angiogenic treatment (cohort 2 only)
a study of intra-thrombus plasmin (human) in acute peripheral arterial occlusion

Conditions: Acute Peripheral Arterial Occlusion

Summary: the primary purpose of this phase 2 study is to optimize plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. the study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. the study will also assess safety and tolerability of plasmin at 150 and 250 mg doses.


Eligibility criteria:
inclusion criteria: * unilateral limb ischemia - society of vascular surgery categories i and iia * onset of symptoms less than or equal to 14 days * thrombosed infrainguinal bypass graft or native artery * diagnosis by arteriography of occlusive thrombus in graft or artery * ability to embed the infusion catheter into the thrombus * women of childbearing potential must use contraception and have a negative pregnancy test exclusion criteria: * any medical or social condition that may interfere with study participation * women who are pregnant or lactating * hemorrhagic stroke history * thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year * intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months * major surgery, organ biopsy, or major trauma within the past 10 days * lumbar puncture or non-compressible arterial puncture in the past 10 days * intraocular surgery within the past 10 days * active gastrointestinal or organ bleeding * uncontrolled arterial hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg) * known intracranial neoplasm, aneurysm, or arteriovenous malformation * current bleeding diathesis * platelet count \<75 x 10e9/l * active graft infection * occlusion occurred within one month of synthetic graft placement * occlusion occurred within 6 months of autologous graft placement * a sequential composite graft with dual outflows to correct multiple occlusions * medically unable to tolerate an open vascular procedure * known prothrombotic state * hemoglobin \<10.0 g/dl * impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine \>2.0 mg/dl * treatment with a full dose plasminogen activator (pa) within the last 48 hours * treatment with a glycoprotein iib/iiia class of platelet inhibitor within the past 5 days * treatment with oral anticoagulants, and with an international normalized ratio of \>1.7

Keywords: acute limb ischemia